An observational study in Gastroparesis, sponsored by University of Florida. Terminated at 1 site in United States. Per ClinicalTrials.gov, last updated 2013-05-20.
Sponsored by University of Florida · Observational
The project will involve conducting a Needs Assessment for Gastroparesis patients and their caregivers with the goal of identifying quality of life issues associated with this disease. Identifying these issues will ameliorate management and support systems for gastroparesis currently existent in the community and, hopefully, provide information for the establishment of more resources to assist the patients and their families.
This project will involve: a) distributing questionnaires to up to 200 participants (100 patients and 100 caregivers) at the Shands Gastrointestinal clinic and b) focus groups including patients, medical provider, and the clinic case manager. The questionnaires will provide information on the relative effect of gastroparesis on the quality of life of the patients and their caregivers. Assessment of this needs assessment will then help identify areas of potential resource improvement and mobilization to provide support for the patients and their family members.
307 studies on the registry are indexed under Gastroparesis; 67 are open to participants now.
This study's enrollment of 68 is below the median of 100 across 77 observational studies indexed under Gastroparesis.
Browse Gastroparesis studies →University of Florida is the lead sponsor of 1,254 studies on the registry; 201 are open to participants now.
Of its 170 completed or terminated interventional studies of FDA-regulated products, 136 (80%) have results posted.
Counted across the registry records on this site, refreshed daily.
The research plan involves reviewing patient records to identify potential subjects. Questionnaires will be distributed to gastroparesis patients and their caregivers during their visit to the GI clinic at the day of enrollment and at six-month intervals for a two-year follow-up period, after informed consent has been obtained. Patients and caregivers will also be recruited by telephone. Gastroparesis patients, who have an established patient-physician relationship with Dr. Sultan, will be contacted by telephone in order to inquire about their interest in participating in the study. The details of the study, including the questionnaires, risks, and potential benefits will be discussed over the phone. Then, if patients and/or their caregivers are willing to participate in the study, the informed consent forms and the questionnaires will be mailed to them with a posted envelope to be returned to Dr. Sultan by mail.
Exclusion Criteria:
Score in a Quality of life assessment Questionnaire
Time frame: During the clinicial visit at the day of enrollment(Day 1)
Score in a Quality of life assessment Questionnaire
Time frame: 1st follow-up, at 6 months from Date of enrollment
Score in a Quality of life assessment Questionnaire
Time frame: 2nd follow-up, at 12 months from date of enrollment
Score in a Quality of life assessment Questionnaire
Time frame: 3rd follow-up, at 18 months form date of enrollment
Score in a Quality of life assessment Questionnaire
Time frame: 4th(last) follow-up, At 24 months form date of enrollment
This study is terminated, as verified in May 2013. You cannot join it, but the record below documents what was studied.
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University of Florida